Emerging Vulnerabilities and Risks in Therapy Manufacture: Cell and Gene Therapy Production as an Emerging Domain of Critical Infrastructure

Abstract

Cell and gene therapies derive from a substantial manipulation of cells or the application of gene editing techniques. They are promising products because they enable therapy personalisation, are potentially helpful for treating rare or resistant diseases, and may become useful in future epidemics.Because of this strategic worth, the infrastructure needed for manufacturing these therapies isturning into a subdomain within the domain of critical infrastructures (CIs), understood as the structures whose operation is key for the integrity and security of a nation. This paper analyses whycell and gene therapy infrastructure can be considered as an emergent CI domain, stressing three aspects: automated manufacturing equipment; software solutions (including the growing adoption of artificial intelligence and cloud technology); and human expertise. These complex manufacturing systems, which are becoming increasingly automated and digitalised, may be surrounded by new risks and vulnerability points, which requires adequate regulatory solutions and governance initiatives. A comprehensive approach is therefore advanced here, where therapy manufacture has medical and technological relevance, but is equally crucial from the viewpoint of nations’ public health and internal stability.

Publication DOI: https://doi.org/10.1017/err.2024.56
Divisions: College of Business and Social Sciences > School of Social Sciences & Humanities > Sociology and Policy
College of Business and Social Sciences
College of Business and Social Sciences > School of Social Sciences & Humanities > Centre for Health and Society
Aston University (General)
Funding Information: This study has been carried out with funding from the UK Engineering & Physical Sciences Research Council (EPSRC), under the grant reference EP/P006485/1, for the Future Targeted Healthcare Manufacturing Hub based at University College London (UCL). We wo
Additional Information: Copyright © The Author(s), 2024. Published by Cambridge University Press. This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use,distribution and reproduction, provided the original article is properly cited.
Publication ISSN: 1867-299X
Last Modified: 26 Nov 2024 08:16
Date Deposited: 04 Nov 2024 13:52
Full Text Link:
Related URLs: https://www.cam ... DA4EB160E5ADA8F (Publisher URL)
PURE Output Type: Article
Published Date: 2024-10-10
Published Online Date: 2024-10-10
Accepted Date: 2024-09-30
Authors: Bicudo, Edison
Brass, Irina

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